Senior Process Development Engineer

Randstad Malaysia; Kuala Lumpur; On-site; MYR 250,000 - 380,000; Full time

Job summary

Randstad Malaysia's client, a global leader in advanced medical technology, seeks a Senior Process Development Engineer (Supplier Quality) to own supplier quality, qualification, and CAPA activities across global suppliers.

You will bridge Design Engineering and manufacturing to ensure incoming materials and external processes meet ISO 13485, IATF 16949, and 21 CFR Part 820 standards, while leading 8D/DMAIC style investigations.

Qualifications

• Bachelor’s Degree in Engineering (Mechanical, Manufacturing, Materials, Industrial, Chemical, Biomedical, or related discipline).
• Minimum of 9 years hands-on engineering experience in SQE, Process Development, or Component Engineering in a regulated manufacturing environment.
• Experience with ISO 13485 / ISO 9001 / IATF 16949 or 21 CFR Part 820 preferred.
• Strong data-driven root cause analysis and statistical methods (8D, DMAIC, SPC, Gage R&R, CpK, Minitab).

Responsibilities

• Supplier Evaluation & Onboarding: assess potential and new supplier candidates; provide technical leadership for component industrialization.
• Component Specification & Qualification: collaborate with Design Engineering; generate test protocols; monitor validation; approve components.
• Inspection Systems & Metrology: develop and validate inspection tools; establish incoming inspection procedures; train inspection personnel.
• Root Cause & Defect Analysis: lead investigations for non-conformances; formulate CAPA/SCAR dispositions with suppliers.
• Design for Manufacturability: review early design specs for manufacturability and yield optimization.
• Leadership & Team Mentorship: provide technical guidance to inspection and support teams.

Skills

Supplier Quality Engineering

Process Development

CAPA/SCAR

Statistical methods

Stakeholder management

Education

Bachelor's Degree in Engineering

Tools

SPC

Minitab

Gage R&R

CAPA system

Job description

Our client is a global leader and Fortune 500 innovator in advanced medical technology and life-transforming healthcare solutions. Recognized worldwide for clinical excellence, cutting-edge innovation, and world-class manufacturing standards, their state-of-the-art facility in Penang is expanding to support the continuous delivery of high-reliability, patient-critical products across the globe.

We are seeking an experienced Senior Process Development Engineer (Supplier Quality) to take ownership of component quality, technical supplier qualification, and supplier-driven continuous improvement initiatives.

In this critical role, you will act as the technical bridge between global suppliers, Design Engineering, and manufacturing operations—ensuring incoming materials and external manufacturing processes meet stringent international quality, regulatory, and performance benchmarks.

the job.

• Supplier Evaluation & Onboarding: Assess potential and new supplier candidates for technical capability, manufacturing robustness, and quality compliance; provide direct technical leadership for component industrialization and introduction.

• Component Specification & Qualification: Collaborate with Design Engineering on component selection and emerging technologies; generate test protocols, monitor validation runs, analyze reliability, and formally approve components for production use.

• Inspection Systems & Metrology: Develop, source, and validate inspection tools, fixtures, and metrology equipment; establish robust incoming inspection procedures and lead technical training for inspection personnel.

• Root Cause & Defect Analysis: Lead technical investigations for incoming material non-conformances, manufacturing yield issues, and field failures; formulate risk-based dispositions and partner with suppliers to implement robust Corrective and Preventive Actions (CAPA / SCAR).

• Design for Manufacturability (DFM): Review and critique early-stage design specifications, ensuring component manufacturability, critical parameter definition, and quality yield optimization.

• Leadership & Team Mentorship: Provide technical guidance and operational supervision to incoming inspection and technical support teams.

the experience.

• Bachelor’s Degree in Engineering (Mechanical, Manufacturing, Materials, Industrial, Chemical, Biomedical, or related discipline).

• Minimum of 9 years of hands-on engineering experience, with a proven track record in Supplier Quality Engineering (SQE), Process Development, or Component Engineering within a highly regulated manufacturing environment (Medical Device, Automotive, Semiconductor, or Advanced Aerospace).

• Deep practical knowledge of supplier audits, engineering change control, Supplier Corrective Action Requests (SCAR), production part approval processes, material control, and risk management (ISO 13485 / ISO 9001 / IATF 16949 / 21 CFR Part 820 standards preferred).

• Proven expertise in data-driven root cause analysis (e.g., 8D, DMAIC, Fishbone, 5-Why) and statistical techniques (SPC, Gage R&R, Process Capability/CpK, Minitab).

• Exceptional negotiation and stakeholder management skills to influence external suppliers and drive accountability across cross-functional internal teams.

skills

no additional skills required

qualifications

no additional qualifications required

education

Bachelor Degree